Effect of Sensory Integration on Gross and Balance on Children With Down Syndrome
Effect of Sensory Integration on Gross Motor Function and Balance in Children With Down Syndrome
To investigate the effect of sensory integration on gross motor function in children with Down syndrome.
To investigate the effect of sensory integration on balance in children with Down syndrome.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
This study will be delimited to:
- sixety children with Down syndrome, ranging in age from3 to 5 years.
- Children will be divided randomly into two groups of equal number: Control group (Group A) will receive designed physical therapy program and study group (Group B) will receive the same designed physical therapy exercises in addition to sensory integration program.
- All children will be assessed by Gross Motor Function Measure Scale (GMFM-88) and HUMAC balance system before and after the intervention.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: raheel sanad, doctoral
- Número de teléfono: 01018263304
- Correo electrónico: raheelsanad90@gmail.com
Ubicaciones de estudio
-
-
-
Cairo, Egipto, 02
- Reclutamiento
- Abo EL resh hospital
-
Contacto:
- raheel sanad, master
- Número de teléfono: 01018263304
- Correo electrónico: raheelsanad90@gmail.com
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- All children diagnosed as Down syndrome, according to genetic lab reports.
- Their age ranges from 3to 5 years.
- Both genders will be included.
- They are able to stand alone.
- They are able to follow instructions. Their IQ ranges from 65 to 80, according to Stanford Binet Intelligence Scale).
- They had been referred by sensory integration problems (low registration and seeking behavior).
Exclusion Criteria:
Patients will be excluded from the study if they have any of the following:
- Persistent heart disease.
- Severe cognitive impairments.
- Recent surgical interference in the lower limbs.
- Obese children (BMI > 95).
- Patients with hip subluxation.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: CONTROLLED GROUP
Children in this group will receive designed physical therapy program for 60 minutes, 3 times per week for 3 months
|
Participants in the controlled group will receive a designed physical therapy program for 60 minutes,three times per week ,for 3 months. Participants in the study group will receive a designed physical therapy program for 30 minutes followed by a sensory integration program for 30 minutes,three times per week for 3 months. the designed physical therapy will include balance and strengthening exercises on the other hand sensory integration program will include different textured surfaces, vistebular stimulation |
|
Experimental: STUDY GROUP
Children in this group will receive the same designed physical therapy exercises for 30 minutes and sensory program for other 30 minutes three times per week for 3 months.
|
Participants in the controlled group will receive a designed physical therapy program for 60 minutes,three times per week ,for 3 months. Participants in the study group will receive a designed physical therapy program for 30 minutes followed by a sensory integration program for 30 minutes,three times per week for 3 months. the designed physical therapy will include balance and strengthening exercises on the other hand sensory integration program will include different textured surfaces, vistebular stimulation |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
balance measured by Stability Score of the Clinical Test of Sensory Interaction on Balance(CTSIB) using HUMAC Balance system
Periodo de tiempo: 3 monthes
|
balance will be assessed by the results of stability score of the Clinical Test of Sensory Interaction on Balance (CTSIB ) using HUMAC Balance system the stability score will be recorded at four conditions 1_child stand on stable surface with open eye 2_child stand on stable surface with closed eye 3_ child stand on foam surface with open eye 4_ child stand on foam surface with closed eye
|
3 monthes
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
gross motor function will be assessed by Gross motor function measurement-88 scale
Periodo de tiempo: 3 monthes
|
The motor function skills of all children in the study will be measured by Gross Motor Function Measurement-88 scale which is a criterion based observational measure.
Standing and walking dimensions only will be selected to be tested
|
3 monthes
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Manifestaciones neurológicas
- Enfermedades del Sistema Nervioso
- Enfermedades Genéticas Congénitas
- Manifestaciones neuroconductuales
- Anomalías congénitas
- Anomalías Múltiples
- Discapacidad intelectual
- Trastornos cromosómicos
- Enfermedades y anomalías congénitas, hereditarias y neonatales
- Síndrome de Down
Otros números de identificación del estudio
- Raheel _SI_2025
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Participations who meet the eligibility criteria will be allocated by simple randomization via sealed opaque envelopes into two matched groups by an independent person:
• Group A (control group): Children in this group will receive designed physical therapy program for 60 minutes, 3 times per week for 3 months Group B (study group): Children in this group will receive the same designed physical therapy exercises for 30 minutes and sensory program for other 30 minutes three times per week for 3 months
Marco de tiempo para compartir IPD
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
- CIF
- CÓDIGO_ANALÍTICO
- RSC
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
producto fabricado y exportado desde los EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .